Drug Firm Investigated FDA Officials

April 15, 2010
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"For more than two months in late 2008, private investigators working for a drug company gathered information on Janet Woodcock, a high-ranking official at the Food and Drug Administration -- unearthing details about her husband, two daughters, and in-laws, and re-tracing her steps on a business trip she took to Thailand,"Politico reports.

"The drug company, Amphastar Pharmaceuticals, paid more than $100,000 to Kroll, the New York-based private investigative firm, to uncover the information about Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, who oversees the agency’s new-drug approvals.

Kroll also investigated a second FDA official on behalf of the drug company -- Moheb Nasr, director of the FDA’s Office of New Drug Quality Assessment, creating a file on him that included his birth date, the price he paid for his home, and details of his education and professional background.

At one point, the investigators hired a freelance reporter to use her status as a journalist to request Woodcock’s emails, phone records, voicemails, calendar and expense reports, among other documents -- without mentioning that she was being paid for her efforts by a private investigative firm."

For more details unearthed by Politico, please read the full article by clicking on the source link below.

If there was any doubt that the pharmaceutical cartel has few scruples when it comes to getting or maintaining market control, the latest rounds of revelations should put those doubts to rest. And although I’m not a fan of the US Food and Drug Administration (FDA), the fact that a pharmaceutical company is snooping through the private lives of high ranking FDA officials is disconcerting.

It only adds to suspicions that drug companies are willing to employ highly questionable, if not downright illegal, strategies to protect their bottom line.

According to Politico, “Amphastar says the investigation was done in order to find out if Woodcock or Nasr was unfairly favoring a competitor in the drug approval process and that it did nothing wrong.”

Why Did Amphastar Investigate FDA Officials?

Back in January, an article published in the Los Angeles Times reported that Amphastar Pharmaceuticals Inc. was appealing the FDA's rejection of a complaint alleging Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, had a conflict of interest that should have barred her from the deliberations over their generic heparin application.

“At first glance, Woodcock's alleged miscue -- the basis of the conflict allegations -- may not seem obvious. It springs from her role in ending a crisis in which contaminated heparin was sickening and sometimes killing users. The crisis spread panic among patients and sparked a storm of criticism of the FDA.

Woodcock and her aides responded by creating a task force charged with finding the source of the problem, and Woodcock, who became a member of the medical detective team, co-wrote a scientific paper that identified a contaminant as the culprit.

But Amphastar points out that Woodcock's collaborators in the article included scientists from Momenta Pharmaceuticals Inc. of Cambridge, Mass., which is Amphastar's rival in the race to market a highly lucrative generic form of heparin.

At the time of the crisis, Amphastar and Momenta had competing drug applications under review by Woodcock's office.

But what appears to worry Amphastar -- and raises a corner of the curtain on drug industry's arcane maneuvering -- is not just that the FDA, perhaps influenced by Woodcock, might oppose the company's application to market generic heparin.

It's that Amphastar, which filed its application two years earlier than Momenta, might see both applications approved at the same time -- meaning that Amphastar would not get the head start it says it deserves.”

Paying more than $100,000 to dig up potential dirt on Woodcock to protect their head start on the market may seem steep to some, but it’s really just a drop in the bucket for most pharmaceutical companies. And whether you consider this kind of snooping right or wrong, it’s likely not as unusual as you might think. After all, other pharmaceutical companies have gone as far as creating “hit lists” of doctors to be "neutralized" or discredited because they were critical of the company’s dangerous wares.

My primary concern with this whole affair is this: Are we becoming too accustomed to and accepting of “mafia tactics” from pharmaceutical companies?

Amphastar swears their actions were legal, but are their actions “right”?

It is my belief that we are indeed becoming numb to the shenanigans of Big Pharma, and not enough is done to curtail their ever expanding reach.

Perhaps Amphastar was indeed looking for something that would prove Woodcock had given their competitor an unfair advantage, but how do we know they weren’t also looking for something more personal they could hold against her to force her to dance to their tune?

According to Politico, the private investigators could not find any improper connections between Woodcock and Amphastar’s competitor, Momenta Pharmaceuticals.

Overall, I agree with Senate Finance Committee Chairman Max Baucus, who is quoted as saying that “Pharmaceutical companies should be focusing on getting their drugs approved based on health research and science rather than wasting their resources hiring private investigators to snoop around the lives of FDA regulators and their families.”

This case certainly brings to the forefront the seedier side of the Pharma Cartel, and it will be interesting to see if Baucus is able to get an answer to his question about how often private detectives target public officials.

If he does, I have a feeling we may all be in for a big shock.

One can only guess how many times public officials hired to protect your health and welfare have been pressured to do the wrong thing, just because of something unearthed in their private lives.